Analysis of the Immune Infiltrate in Lesional Skin During Anti-interleukin 23 (IL-23) Therapy in Patients With Moderate-severe Plaque Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Identify the cellular source of key cytokines involved in disease recurrence or persistence of at least a psoriatic lesion
研究概览
简要总结
Psoriasis is an immune-mediated inflammatory skin disease characterized by the presence of erythematous and itchy plaques.
Psoriasis has a multifactorial pathogenesis, environmental and genetic factors contribute to its development.
Although interleukin-23 blockade has been shown to be highly effective in the treatment of psoriasis, relapses have occurred during therapy.
Our study aims to identify the cellular source of key cytokines involved in disease recurrence or persistence of at least one psoriatic lesion in patients affected by moderate- severe psoriasis treated with an anti-IL-23 biologic drug. The immune infiltrate of resistant or relapsed plaques during anti-IL-23 therapy will be analysed from skin biopsies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate-severe psoriasis PASI>10
- •anti IL 23 biologic therapy for at least 6 months (for the group under treatment)
- •during therapy at least one area resistant to treatment or at least one flare of disease (for the group under treatment)
- •patients able to express informed consent
排除标准
- •patients unable to express informed consent
- •patients with complete response to anti IL23, without resistant plaques or disease flare-ups
结局指标
主要结局
Identify the cellular source of key cytokines involved in disease recurrence or persistence of at least a psoriatic lesion
时间窗: through study completion, an average of 1 year
Through the integration of multiparametric immunofluorescence staining with RNA in situ hybridization technology, our study aims to identify the cellular source of key cytokines involved in disease recurrence or persistence of at least one lesion psoriatic lesion in patients with moderate-severe psoriasis, undergoing treatment with anti-IL-23.
次要结局
- immune biomarkers of sustained and prolonged response to treatment(through study completion, an average of 1 year)